MAUDE Adverse Event Report: MEDTRADE PRODUCTS LTD MEDLINE SUREPREP WIPE; WIPE,1ML,SUREPREP NO-STING,BARRIER,FILM

Model Number	FG01227201
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	05/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility on (b)(6) 2024 the patient experienced a skin reaction related to the use of the sureprep wipe.
Additional Manufacturer Narrative
According to the facility on (b)(6) 2024 the patient experienced a skin reaction related to the use of the sureprep wipe.Per the facility the skin was "cleansed with chloraprep" prior to application and the skin irritation was described as "red welts-rash like appearance where the skin prep was applied".Per the facility the patient required prescription "bactroban ointment with every dressing change" and the "rash is clearing up".No additional information is available at this time, and the facility was unable to state the definitive cause of the rash.The initial importer / distributor has requested the device for evaluation.It has been determined that the reported event caused or contribute to serious injury requiring medical intervention, therefore this medwatch is being filed.If any further relevant information is identified or obtained a supplemental medwatch will be submitted.

• Brand Name: MEDLINE SUREPREP WIPE
• Common Device Name: WIPE,1ML,SUREPREP NO-STING,BARRIER,FILM
• Manufacturer (Section D): MEDTRADE PRODUCTS LTD; electra house, electra way; crewe business park; crewe, cheshire CW1 6 GL; UK CW1 6GL
• Manufacturer (Section G): MEDTRADE PRODUCTS LTD; electra house, electra way; crewe business park; crewe, cheshire CW1 6 GL; UK CW1 6GL
• Manufacturer Contact: sue mcloughlin ; electra house, electra way; crewe business park; crewe, cheshire CW1 6-GL ; UK CW1 6GL
• MDR Report Key: 19750034
• Report Number: 3003188818-2024-00001
• Device Sequence Number: 17775224
• Product Code: KMF
• UDI-Device Identifier: 40080196770053
• UDI-Public: 40080196770053
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K051082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: FG01227201
• Device Catalogue Number: MSC1505
• Device Lot Number: 58641
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BACTROBAN AT DRESSING CHANGE; CHLOROPREP PRIOR TO APPLICATION
• Outcome Attributed to Adverse Event: Other
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Ethnicity: Hispanic